Patient Participation Research Articles

Clinical trial results: each patient's participation should count.

This editorial addresses concerns about published clinical trial results of a study on homeopathic treatment for non–small cell lung cancer.

A Study on Internet News for Patient Safety Campaigns: Focusing on Text Network Analysis and Topic Modeling.

Background/Objectives: This study aimed to identify the main issues related to public patient safety campaigns reflected in Korean online news. This study utilized a text-mining method to identify keywords and topics related to patient safety campaigns. Methods: The data collection period was from 1 January 2022 to 31 December 2023, and 4110 news articles were extracted. Through data preprocessing, 2661 duplicated news and 1213 unrelated news were removed, and 236 news were selected. Using the NetMiner program, keyword co-occurrence frequency calculation, keyword centrality analysis, and topic modeling analysis were performed. Results: The results showed that the most frequently mentioned keywords with high degree centrality, betweenness centrality, and closeness centrality in online news were "hospital", "medical", "medicine", "project", and "treatment". The topics of online news related to the patient safety campaign were "patient-centered care for medical safety", "health promotion projects at a regional institution", "hand hygiene education to prevent infection", "healthcare quality improvement through the Mint Festival", and "safe use of medicines". Conclusions: This study analyzed patient safety campaign news topics using text network analysis and topic modeling. It was confirmed that patient safety campaigns are essential for fostering a patient safety culture, improving medical quality, and encouraging patient participation in hospitals. Therefore, to build a safe medical environment, it is necessary to establish an effective patient safety campaign for not only medical staff providing medical care, but also patients and their caregivers, and for this, cooperation and participation from various professional occupations are necessary.

Trustworthy Artificial Intelligence in Dentistry: Learnings from the EU AI Act.

Artificial intelligence systems (AISs) gain relevance in dentistry, encompassing diagnostics, treatment planning, patient management, and therapy. However, questions about the generalizability, fairness, and transparency of these systems remain. Regulatory and governance bodies worldwide are aiming to address these questions using various frameworks. On March 13, 2024, members of the European Parliament approved the Artificial Intelligence Act (AIA), which emphasizes trustworthiness and human-centeredness as relevant aspects to regulate AISs beyond safety and efficacy. This review presents the AIA and similar regulatory and governance efforts in other jurisdictions and lays out that regulations such as the AIA are part of a complex ecosystem of interdependent and interwoven legal requirements and standards. Current efforts to regulate dental AISs require active input from the dental community, with participation of dental research, education, providers, and patients being relevant to shape the future of dental AISs.

Working Status in Patients With Untreated Unruptured Intracranial Aneurysms: A Descriptive Longitudinal Study

BACKGROUND AND OBJECTIVES: Many patients with unruptured intracranial aneurysms (UIAs) remain untreated if the risk of treatment exceeds the estimated risk of aneurysm rupture, potentially leading to diagnosis-related stress and anxiety. Working status may serve as a marker for the total level of function including mental health and psychological burden of the condition. The aim of the study was to assess the working status before and after a diagnosis of an untreated UIA. METHODS: This was a retrospective nationwide registry-based descriptive longitudinal study. It included all working-age patients diagnosed with an UIA in Norway between 2008 and 2018 and 1:1 age-matched and sex-matched controls without a diagnosis of an intracranial aneurysm that were randomly selected from the Norwegian population. The history of sickness absence in the period of 1 year before and after diagnosis was retrieved from The Norwegian Labour and Welfare Administration records and compared between the groups. RESULTS: In total, 2141 patients and 2141 controls were included in the study. Proportion of working patients decreased from 62.1% (95% CI 60.0%-64.1%) 1 year before the diagnosis to 51.3% (95% CI 49.1%-53.4%) 1 year after the diagnosis (P < .001). In comparison, the proportion of working controls decreased from 77.9% (95% CI 76.1%-79.6%) 1 year before day 0 to 73.4% (95% CI 71.5%-75.2%) 1 year after day 0 (P = .001). The odds of working were 86.7% lower among the patients than among the controls (odds ratio 0.133, 95% CI 0.091-0.194; P < .001) when controlled for the baseline working status. The older the individuals, the less likely they were to work (odds ratio 0.908, 95% CI 0.889-0.926; P < .001). CONCLUSION: The work participation of patients diagnosed with UIA is low prediagnosis compared with the general population and decreases significantly postdiagnosis.

Abstract B123: Multilevel influences on Black and Hispanic/Latine patient participation in early phase cancer clinical trials

Abstract Black and Hispanic/Latine patients are disproportionately burdened by cancer yet underrepresented in cancer clinical trials. Diverse participation in cancer clinical trials is essential to identify potential group differences in risks and benefits and to ensure equitable access to cutting-edge therapeutics. Prior research has focused on barriers to representation in later phase trials with less focus on early phase cancer clinical trials (EPCCTs). EPCCTs may include unique barriers to representation based on safety focus and intensive monitoring. We investigate multi-level influences on EPCCT participation for Black and Hispanic/Latine patients through in-depth qualitative interviews with (n=30) Black or Hispanic/Latine metastatic cancer patients and (n=30) oncology providers/staff from two community practices. Using the Ecological Model as a guiding framework, we explored facilitators and barriers to diverse EPCCT participation at the patient level, provider level, health system/policy level, and community level. We utilized Rapid Qualitative Inquiry to gain pragmatic, accurate understanding. At the patient level, we identified informational (e.g., understanding of cancer), emotional (e.g., trust), and instrumental (e.g., transportation) influences on Black and Hispanic/Latine participation. The most pervasive barrier to EPCCT inclusion was lack of invitation for Black and Hispanic/Latine patients. At the provider/staff level, key barriers to representation included low EPCCT knowledge among providers, preconceptions about barriers for Black and Hispanic/Latine patients, and perceived loss of control/relationship with patients/caregivers. At the health system/policy level, critical barriers included insufficient time to discuss EPCCTs, concerns about impact of trials on systems (e.g., wait-time for scans), and provider discomfort with referral process (sending patients to Phase I team without specific trial knowledge). At the community level, salient influences on patient decision-making were identified (e.g., peers, youtube). We conducted a systemwide survey of (n=81) oncology providers and their attitudes, beliefs, and behaviors regarding EPCCTs; we determined how attitudes and beliefs related to EPCCT referral behaviors. We have planned interventions to mitigate each barrier and leverage each facilitator to increase representation. It is critical to identify and address relevant local barriers to ensure equitable access to novel therapeutics and generalizability of scientific discoveries. Citation Format: Jessica Lewis, Amy Smoyer, Erin Singleton, Marcella Nunez-Smith, Imran Saeed, Patricia LoRusso. Multilevel influences on Black and Hispanic/Latine patient participation in early phase cancer clinical trials [abstract]. In: Proceedings of the 17th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2024 Sep 21-24; Los Angeles, CA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2024;33(9 Suppl):Abstract nr B123.

Abstract B004: Reaching the Community: Collaborating with Black/African American Metastatic Breast Cancer Patients and Advocates

Abstract Background: In America, Black metastatic breast cancer (MBC) patients are disproportionately underrepresented in clinical research, of which the majority of participants are white - leaving research less representative of Black patients. Interventions: To increase the sustainable participation of Black MBC patients in clinical research, Count Me In (CMI)—a cancer research initiative based at the Broad Institute of MIT and Harvard—partnered with the Tigerlily Foundation (TLF), a patient advocacy organization, to develop an equitable, collaborative approach connecting CMI researchers with Black MBC patients to create culturally relevant educational materials for the Black MBC community. Findings: Participating Black MBC patients developed the following materials: a tri-fold brochure, two types of informational postcards, and a social media digital toolbox. The patients co-developed and approved the materials' content and design elements. Materials were also translated into Spanish. Three iterations were drafted until materials were submitted to CMI’s IRB at Dana-Farber Cancer Institute (DFCI) for approval. The distribution strategy for materials to the larger Black MBC community was designed collaboratively with patients. This included sharing information and resources with their local oncology nurse navigators, placing printed materials in community practices, enclosing materials in folders distributed at initial diagnosis, and further connecting with other community-based breast cancer support groups and organizations. During the pilot distribution period - from August 2023 to February 2024 - CMI sent informational packages with materials to 8 different community contacts across the United States. Participating patients had shared contact information of those in their own social network. By the end of the pilot period, 38 new patients registered in CMI identified as having MBC, with 18% self-identifying as Black/African American and 24% self-identifying as Hispanic/Latino - both of which are overrepresentative when compared to the general population of those who self-identify as Black/African American and Hispanic/Latino. Conclusion: CMI and TLF utilized an equitable approach that included patients at the initial planning of a project to the final production and distribution of the materials. Two recommendations could be provided to researchers and organizations from this successful collaborative partnership and pilot. First, patient advocates desire to be involved in creating and sharing resources with their communities. Organizations can honor their commitment with financial and non-financial opportunities. Second, partnering appropriately with patient advocates will increase clinical study representation. The success of this pilot demonstrates how researchers and patients can collectively close the inequities gap and pave the path forward for more equitable cancer research. Citation Format: Colleen M. Nguyen, Eboney D. Thompson, Juanita Miller, Shanette Caywood, Tiana Russell, Sue Steele, Virginia Leach, Lizzie Wittig, Taisha Hendrickson, Kolbe Phelps, Priyanka Bhakhri. Reaching the Community: Collaborating with Black/African American Metastatic Breast Cancer Patients and Advocates [abstract]. In: Proceedings of the 17th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2024 Sep 21-24; Los Angeles, CA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2024;33(9 Suppl):Abstract nr B004.

Exploring a role for community pharmacists in the identification of alcohol-related liver disease: a qualitative interview study with professionals, patients, and the public.

To explore the views and attitudes of professionals, patients and the public to a role for community pharmacists in the identification of alcohol-related liver disease (ArLD). Semi-structured interviews were conducted with a purposive sample of patients with ArLD, members of the public, pharmacy staff, and clinicians managing patients with ArLD across the Wessex region of south England. The interviews explored experiences of alcohol, ArLD and health advice in pharmacies and elicited views of what a pharmacist role in identifying ArLD could entail and factors influencing this. Transcripts were analysed using reflexive thematic analysis. Twenty-six participants were interviewed and three themes were generated: (i) acknowledging, seeking help and engaging with a hidden problem; (ii) professional roles, boundaries and attributes; (iii) communication, relationships, collaboration and support. Participants reported key challenges to identifying people at-risk of ArLD. Offering testing for ArLD was perceived to motivate engagement but there were concerns about pharmacists performing this. A role was mostly seen to be finding people at-risk and engaging them with further care such as referral to liver services. This was perceived to require developing interprofessional collaborations, remuneration and training for pharmacy staff, and community-based liver testing. Professionals, patient and public participants recognized a role for pharmacists in the identification of ArLD. This was envisaged to incorporate educating pharmacy users about ArLD risk, and identifying and directly engaging those at-risk with liver and support services through development of interprofessional collaborations. The findings of this study support and can inform future work to develop this role.

Abstract B161: Has much changed? A scoping review on the nature of racial/ethnic disparities in endometrial cancer research since the release of the Society of Gynecologic Oncology statement

Abstract Introduction: Endometrial cancer is prevalent in the United States and has well documented disparities across race and ethnicity. The Society of Gynecologic Oncology’s (SGO) 2014 review on racial/ethnic disparities in gynecologic cancers, including endometrial, ended with a call to action to increase research on endometrial cancer disparities and to shift focus from identification of disparities to solutions. With a decade passed since the publication, it is unknown how the landscape of research on racial/ethnic disparities in endometrial cancer has changed. Objectives: A scoping review was conducted to identify the nature of research on racial/ethnic disparities in endometrial cancer since the publication of the SGO review in 2014, including summarizing the proportion of studies that focused on disparities across patient, provider and systemic spheres. Secondarily, to understand the proportion and nature of studies that proposed a solution to the identified racial/ethnic disparities. Methods: Scoping review was designed following the PRISM-SCa protocol. MEDLINE, EMBASE and Web of Science were searched to identify relevant studies. Inclusion criteria included: publication following the SGO statement, in English, published in the United States, on human subjects, primary study, specifically mentioned a racial or ethnic disparity in endometrial cancer. Reviews, meta- analyses, and opinion pieces were excluded. Relevant studies were coded for nature of disparity and solutions offered using a standardized data abstraction tool. Results: 182 studies were included, 141 (77.5%) focused on racial disparities, 34 (18.8%) on racial and ethnic, and 7 (3.8%) on ethnic, mainly Hispanic. Of those, 138 (75.8%) focused only on Black or African American disparities. When evaluating the level at which the disparity was identified, 116 (63.7%) were at the patient level, 25 (13.7%) at the provider level, 21 (11.5%) systemic, and 20 (11.5%) identified disparities on multiple levels. Half of the studies included offered solutions (91, 50.0%), however, the majority of the solutions suggested an increase in disparity research (32, 35.2%) and expanding clinical trials (15, 16.5%); many of these were included as further directions of the study itself. Other solutions included expanding access to health care (15, 16.5%), enhancing patient education (12, 13.2%), increasing patient participation in care (4, 4.4%), increasing diversity in the workforce (1, 1.1%), and other (12, 13.2%). Conclusions: Though much research on racial/ethnic disparities in endometrial cancer has been conducted since the SGO statement, many studies focused on patient-level factors instead of challenging provider/systemic level factors. When it came to a call to action, only half of the studies discussed a solution, the majority of which were included as future directions and suggested expansion of research. A small minority of articles outlined tangible solutions to the disparity discussed, leaving a continued need to shift research from identification of the disparity to creating solutions. Citation Format: Sarah Battiston, Victoria Kelley, Molly Wilson, Morolayo Ilori, Katerina Furman, Layla Hak, Madison Miller. Has much changed? A scoping review on the nature of racial/ethnic disparities in endometrial cancer research since the release of the Society of Gynecologic Oncology statement [abstract]. In: Proceedings of the 17th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2024 Sep 21-24; Los Angeles, CA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2024;33(9 Suppl):Abstract nr B161.

Implementation of an electronic prospective surveillance model for cancer rehabilitation: a mixed methods study protocol

IntroductionAn electronic prospective surveillance model (ePSM) uses patient-reported outcomes to monitor impairments along the cancer pathway for timely management. Randomised controlled trials show that ePSMs can effectively manage cancer-related impairments....

AI-Powered Telemedicine for Automatic Scoring of Neuromuscular Examinations.

Telemedicine is now being used more frequently to evaluate patients with myasthenia gravis (MG). Assessing this condition involves clinical outcome measures, such as the standardized MG-ADL scale or the more complex MG-CE score obtained during clinical exams. However, human subjectivity limits the reliability of these examinations. We propose a set of AI-powered digital tools to improve scoring efficiency and quality using computer vision, deep learning, and natural language processing. This paper focuses on automating a standard telemedicine video by segmenting it into clips corresponding to the MG-CE assessment. This AI-powered solution offers a quantitative assessment of neurological deficits, improving upon subjective evaluations prone to examiner variability. It has the potential to enhance efficiency, patient participation in MG clinical trials, and broader applicability to various neurological diseases.

Developing an Individualized Patient Decision Aid for Chronic Coronary Disease Based on the ISCHEMIA Trial: A Mixed-Methods Study

BACKGROUND: Pursuing initial invasive or conservative management of chronic coronary disease (CCD) is a preference-sensitive decision that should include shared decision-making. Communicating the benefits of either approach is challenging, as individual patients rarely achieve the population-averaged outcomes reported in clinical trials. Our objective was to develop a patient decision aid (PDA) with patient-specific estimates of outcomes for initial invasive versus conservative management of CCD, based on the ISCHEMIA trial (International Study of Comparative Health Effectiveness With Medical and Invasive Approaches). METHODS: This was a multiphase mixed-methods study using focus groups of outpatients with CCD, caregivers, clinicians, and researchers. Focus groups were held in Kansas City, MO and New York City, NY between September 2021 and June 2022. Patients with CCD were included if they had a positive stress test within 1 year. Phase 1 focused on patient priorities for outcomes to guide treatment decisions. Phase 2 involved PDA development and refinement. Phase 3 involved further refinement and member checking. Key themes involving shared decision-making and treatment preferences were elicited from focus groups using a deductive approach to develop a PDA representing the outcomes most important to patients. RESULTS: Of 46 patient and caregiver participants, the mean age was 63.5 years, 53% were female, 61% were White, 24% were Black, and 9% were Hispanic. When deciding between treatments, participants valued shared decision-making but generally deferred decisions to clinicians. The outcomes most important to participants were survival and quality of life, followed by physical functioning and symptoms. To represent these outcomes, participants favored simple visualizations, such as a speedometer or health meter. When deciding between treatment options, participants preferred to use the PDA collaboratively with a clinician instead of as a stand-alone tool. CONCLUSIONS: Our novel, patient-centered approach to developing a PDA for CCD with patient-specific outcomes has the potential to rapidly translate clinical trial results to individual patients and support shared decision-making.

User-Centered Design and Usability of Voxe as a Pediatric Electronic Patient-Reported Outcome Measure Platform: Mixed Methods Evaluation Study.

Electronic patient-reported outcome measures (ePROMs) are standardized digital instruments integrated into clinical care to collect subjective data regarding patients' health-related quality of life, functional status, and symptoms. In documenting patient-reported progress, ePROMs can guide treatment decisions and encourage measurement-based care practices. Voxe is a pediatric and user-centered ePROM platform for patients with chronic health conditions. We aimed to describe the user-centered design approach involving feedback from end users and usability testing of Voxe's platform features to support implementation in a pediatric health care setting. Purposive sampling was used to recruit patients aged 8-17 years from 2 chronic illness populations in 2 pediatric hospitals in Canada. Patients' health care team members were also purposively recruited. One-on-one iterative testing sessions were conducted digitally by research team members with participants to obtain feedback on the appearance and functionalities of the Voxe platform prototype. Patients and health care providers (HCPs) completed Voxe-related task-based activities. International Organization for Standardization key performance indicators were tracked during HCP task-based activities. HCPs also completed the System Usability Scale. To test platform usability, the think-aloud technique was used by participants during the completion of structured tasks. After completing all task-based activities, patient participants selected 5 words from the Microsoft Desirability Toolkit to describe their overall impression and experience with the Voxe platform. Qualitative data about likes, dislikes, and ease of use were collected through semistructured interviews. Feedback testing sessions were conducted with patients and HCPs until Voxe was acceptable to participating end users, with no further refinements identified. Quantitative and qualitative data analysis were completed using descriptive statistics and content analysis. A total of 49 patients and 38 HCPs were recruited. Patients were positive about Voxe's child-centered design characteristics and notification settings. HCPs rated Voxe as user-friendly and efficient, with the time to complete tasks decreasing over time. HCPs were satisfied with the Voxe platform functionalities and identified the value of Voxe's system notifications, summarized display of ePROM results, and its capacity to integrate with electronic medical records. Patients' and HCPs' high satisfaction rates with the Voxe prototype highlight the importance of being responsive to user suggestions from the inception of eHealth platform developments to ensure their efficient and effective design. This paper describes the user-centered creation and usability testing of Voxe as an ePROM platform for implementation into clinical care for pediatric patients with chronic health conditions. As a patient-facing platform that can be integrated into electronic medical records, Voxe aligns with measurement-based care practices to foster quality patient-centered approaches to care. End users' positive feedback and evaluation of the platform's user-friendliness and efficiency suggest that Voxe represents a valuable and promising solution to systematically integrate patient-related outcome (PRO) data into complex and dynamic clinical health care settings. RR2-10.1136/bmjopen-2021-053119.

Varieties of silence – a mixed-methods study exploring reasons and justifications for nondisclosure of the use of complementary therapies to physicians in Finland

BackgroundIn health care, two in three users of complementary therapies (CT) stay silent about their CT use. Disclosure of CT use to physicians is important for patient safety, participation, and shared decision-making. Common reasons for CT nondisclosure include patients´ expectations of physicians’ unaccepting response to disclosure, physicians not asking, and patients believing it is unnecessary. This study aimed to increase understanding of patient silence. We investigated how the reasons for nondisclosure of CT use reported by CT users were associated with the frequency of CT disclosure and how these associations and reported justifications to keep silent reflect patient silence among the study participants.MethodsThis mixed-methods study used existing data from the non-probability-based online survey (n = 6802) targeted to CT users among the general population in Finland. A qualitative structured tabular thematic analysis was conducted for the selected 342 brief texts describing the reasons and justification for not telling physicians about CT use. The associations between the frequency of CT disclosure and the reasons for CT nondisclosure were analysed by crosstabulations and binary logistic regression analysis with SPSS (v28).ResultsThree types of patient silence were revealed. Avoidant silence illustrates the respondents coping with the fear of unwanted response from a physician and avoiding the expected negative consequences of CT disclosure. Precautionary silence exemplifies respondents striving to prevent the reoccurrence of previously experienced frustration of wishes to be seen and heard as CT users. Conditional silence portrays the self-confidence of respondents who assessed their need to disclose CT use to physicians on a case-by-case basis.ConclusionsSilence, for some patients, may serve as a way of warding off past and possible future fears and frustrations related to CT disclosure. It is important to recognise different types of patient silence related to CT disclosure to enhance patient participation and shared decision-making in health care. Efforts are needed to provide health policy decision-makers with information about CT users’ lived experiences with CT communication in health care.

Assessment of the HIV Enhanced Access Testing in the Emergency Department (HEATED) program in Nairobi, Kenya: a quasi-experimental prospective study

Background Persons seeking emergency injury care are often from higher-risk and underserved key populations (KPs) and priority populations (PPs) for HIV programming. While facility-based HIV Testing Services (HTS) in Kenya are effective, emergency department (ED) delivery is limited, despite the potential to reach underserved persons. Methods This quasi-experimental prospective study evaluated implementation of the HIV Enhanced Access Testing in Emergency Departments (HEATED) at Kenyatta National Hospital ED in Nairobi, Kenya. The HEATED program was designed as a multi-component intervention employing setting appropriate strategies for HIV care sensitization and integration, task shifting, resource reorganization, linkage advocacy, skills development and education to promote ED-HTS with a focus on higher-risk persons. KPs included sex workers, gay men, men who have sex with men, transgender persons and persons who inject drugs. PPs included young persons (18–24 years), victims of interpersonal violence, persons with hazardous alcohol use and persons never HIV tested. Data were obtained from systems-level records, enrolled injured patient participants and healthcare providers. Systems and patient-level data were collected during a pre-implementation period (6 March − 16 April 2023) and post-implementation (period 1, 1 May − 26 June 2023). Additional, systems-level data were collected during a second post-implementation (period 2, 27 June − 20 August 2023). HTS data were evaluated as facility-based HIV testing (completed in the ED) and distribution of HIV self-tests independently, and aggregated as ED-HTS. Evaluation analyses were completed across reach, effectiveness, adoption, implementation and maintenance framework domains. Results All 151 clinical staff were reached through trainings and sensitizations on the HEATED program. Systems-level ED-HTS among all presenting patients increased from 16.7% pre-implementation to 23.0% post-implementation periods 1 and 2 (RR = 1.31, 95% CI: 1.21–1.43; p < 0.001). Among 605 enrolled patient participants, facilities-based HTS increased from 5.7% pre-implementation to 62.3% post-implementation period 1 (RR = 11.2, 95%CI: 6.9–18.1; p < 0.001). There were 440 (72.7%) patient participants identified as KPs (5.6%) and/or PPs (65.3%). For enrolled KPs/PPs, facilities-based HTS increased from 4.6% pre-implementation to 72.3% post-implementation period 1 (RR = 13.8, 95%CI: 5.5–28.7, p < 0.001). Systems and participant level data demonstrated successful adoption and implementation of the HEATED program. Through 16 wk post-implementation a significant increase in ED-HTS delivery was maintained as compared to pre-implementation. Conclusions The HEATED program increased overall ED-HTS and augmented delivery to KPs/PPs, suggesting that broader implementation could improve HIV services for underserved persons already in contact with health systems.

Understanding patient and health care provider perceptions of barriers and facilitators to diabetes care in immigrant and refugee populations

BackgroundThere is a lack of literature which assesses both patient and health care provider (HCP) perceptions of barriers and facilitators to diabetes health care in immigrant and refugee populations within the United States. This study uniquely incorporates both cohorts’ perceptions on the same topic to assess for congruency and discrepancies in perspectives.MethodsSurveys were deployed to patients with diabetes and HCPs to solicit perceptions of barriers and facilitators to diabetes care, with the intention to determine similarities and differences between cohorts. A literature review was conducted to explore barriers and facilitators to diabetes care in immigrant/refugee populations in the US to aid in development of the survey used in this study, as no validated survey existed. Broad recruitment strategies were used, including snowball sampling. Descriptive statistics were calculated and reported p-values were derived from a chi-squared or Fisher’s exact test and used for categorical data and a Wilcoxon rank sum or Kruskal–Wallis rank sum test was used for continuous data. Qualitive analysis was completed using the inductive analysis method.ResultsAmong 19 immigrant and refugee patients and 35 HCPs, almost all facilitators to diabetes care were endorsed by patients and HCPs as helpful. The highest ranked facilitator among patients and HCPs was having access to health insurance. Patients rated stress, while HCPs rated lack of health insurance as the biggest barriers to diabetes care for immigrants and refugees. Patients and HCPs differed in perspective on who held primary responsibility for diabetes management. Patients wanted more diabetes education and nutrition support, while HCPs thought understanding patients’ cultural context/sensitivity, providing more education, and having language/translation services were the most important things HCPs can do to care for patients’ diabetes.ConclusionsImmigrant/refugee patients and HCPs largely agree about what factors are most helpful in managing diabetes, with access to health insurance as the greatest facilitator. However, while HCPs identified lack of health insurance as the greatest barrier to care, immigrant and refugee patients cited the role of stress as the greatest challenge in managing their diabetes. There was a striking difference in perception of responsibility for diabetes management, with 89% of patient participants responding that the patient is responsible, while only 17% of HCPs responded that the patient was responsible. Future work should include surveys translated into languages other than English to further elicit the perspective of diabetes care in immigrant/refugee populations. Clinical recommendations based on this study include assessing and supporting patient stressors, assuring patients understand that diabetes management is a partnership, providing culturally tailored diabetes education, and increasing access to health insurance.

Testing home-based exercise strategies in underserved minority cancer patients undergoing chemotherapy (THRIVE) trial: a study protocol.

Higher rates of physical inactivity and comorbid conditions are reported in Hispanic/Latinx and Black cancer patients receiving chemotherapy compared to their White counterparts. Despite the beneficial effect of exercise training for cancer patients, rates of participation in exercise oncology clinical trials are low among disadvantaged and racial and ethnic minority groups. Here, we will examine the effect of an exercise intervention using a novel, accessible, and cost-effective home-based exercise approach among Hispanic/Latinx and Black cancer patients receiving chemotherapy on exercise participation and cardiovascular disease risk. The THRIVE trial is an 8-month prospective, three-arm study of 45 patients who are randomized in a 1:1:1 fashion to a supervised exercise intervention (SUP), unsupervised exercise (UNSUP), or an attention control (AC) group. Eligible patients include those with breast, colorectal, or prostate cancer, who are sedentary, overweight or obese, self-identify as Hispanic/Latinx or Black, and plan to receive chemotherapy. Patients randomized to the SUP group participate in a home-based 16-week periodized aerobic and resistance exercise program performed three days per week, supervised through video conference technology. Patients randomized to the UNSUP group participate in an unsupervised 16-week, telehealth-based, periodized aerobic and resistance exercise program performed three days per week using the same exercise prescription parameters as the SUP group. Patients randomized to the AC group receive a 16-week home-based stretching program. The primary outcome is changes in minutes of physical activity assessed by 7-day accelerometry at post-intervention. Secondary outcomes include cardiovascular risk factors, patient-reported outcomes, and physical function. Outcome measures are tested at baseline, post-intervention at month 4, and after a non-intervention follow-up period at month 8. The THRIVE trial is the first study to employ a novel and potentially achievable exercise intervention for a minority population receiving chemotherapy. In addition, this study utilizes an intervention approach to investigate the biological and behavioral mechanisms underlying exercise participation in these cancer patients. Results will guide and inform large randomized controlled trials to test the effect of home-based exercise on treatment outcomes and comorbid disease risk in minority patients with cancer undergoing chemotherapy. https://classic.clinicaltrials.gov/ct2/show/NCT05327452, identifier (NCT#05327452).

Revisiting the hospital-issued gown in hospitalizations from a locus of control and patient-centered care perspectives: a call for design thinking.

Patient-centered care (PCC) is the preferred health policy approach that emphasizes responding to individual patient preferences, wishes, and needs. PCC requires active patient engagement. While there has been extensive research on physicians' robes, there is limited research on hospital-issued patient gowns during hospitalizations. How does the gown affect the cognitive-emotional experience of hospitalized patients? How is the gown associated with PCC? The sample of this cross-sectional study consisted of 965 patients who were hospitalized at least once during the past year in a tertiary hospital. Measures were previously published. The gown was strongly associated with lack of control and increased distress, and was negatively associated with patient proactiveness, engagement, and taking responsibility for self-management of chronic illness. Compared to male patients, female patients wearing the gown had stronger negative emotions and cognitively strong associations with the external locus of control, which inhibited engagement. The hospital gown is an unacknowledged barrier to achieving PCC, inhibits patient engagement, and reflects the paradoxes of inadvertently excluding patients' needs from hospital practice. The hospital gown must be modified to protect the patient's voice and enhance engagement. Policymakers are called to apply design thinking to facilitate patient participation in decision-making to accord hospital clothing to PCC and improve healthcare delivery.

Self-Reported Perceptions of Patients and Staff on Participation and Verbal and Social Interactions in High-Security Forensic Psychiatric Care in Sweden.

Studies suggest that experiences of patient participation, as described by both patients and staff, are associated with a significant caring relationship of high quality. This study aimed to investigate staffs' and patients' self-reported perceptions on participation and the frequency and importance of verbal and social interactions in high-security forensic psychiatry. The questionnaire Verbal and Social Interactions (VSI) was used together with the subscale Participation from Quality in Psychiatric Care (QPC). The study was conducted at a large forensic psychiatric clinic in Sweden. Staff and patients rated the frequency of VSI differently while reporting the same perceived degree of patient participation. All categories of VSI were significantly correlated with perceived level of participation with medium or small effect size for the patients. Patients' perceived participation seems to depend on verbal and social interaction within the specific categories 'Showing interest in the patients' feelings, experiences, and behavior' and 'Helping the patients establish structure and routines in their everyday life'. There was, however, a negative association for the latter. The results give a better understanding of what kind of interactions that affect patients' perceived level of participation. Patient participant is a prioritised area for development in forensic psychiatry. The study contributes to a better understanding of what types of interactions that affect the perceived level of participation, while at the same time, it shows important similarities and differences between patient and staff perspectives.

Perceptions of extended-release buprenorphine among people who received medication for opioid use disorder in jail: a qualitative study

BackgroundIncarceration provides an opportunity for health interventions, including opioid use disorder (OUD) treatment and prevention of opioid-related overdoses post-release. All FDA-approved forms of medication for OUD (MOUD) treatment were mandated in several Massachusetts jails in 2019, with some jails offering extended-release buprenorphine (XR-Bup). Little is known about patient perspectives on and experiences with XR-Bup in carceral settings.MethodsWe conducted semi-structured interviews in 2022 with community-dwelling people who received MOUD during a recent incarceration in a Massachusetts jail. We asked participants about their experiences with and perspectives on XR-Bup while in jail. Qualitative data were double-coded deductively and reviewed inductively to identify emergent themes, which were structured using the Theoretical Framework of Acceptability (TFA).ResultsParticipants (n = 38) had a mean age of 41.5 years, were 86% male, 84% White, 24% Hispanic, and 95% continued to receive MOUD at the time of their interview, including 11% receiving XR-Bup. Participants who viewed XR-Bup favorably appreciated avoiding the taste of sublingual buprenorphine; avoiding procedural difficulties and indignities associated with daily dosing in carceral settings (e.g., mouth checks, stigmatizing treatment from correctional staff); avoiding daily reminders of their addiction; experiencing less withdrawal; having extra time for other activities, such as work; and reduction of diversion of MOUD within the jail setting. Participants who viewed XR-Bup less favorably preferred to maintain their daily dosing routine; liked daily time out of their housing unit; wanted to know what was “going into my body everyday”; and feared needles and adverse events. Participants also reported that jail clinicians used XR-Bup for patients who were previously caught diverting sublingual buprenorphine, suggesting limited patient participation in decision-making around XR-Bup initiation in some jails.ConclusionPeople who received MOUD in Massachusetts jails had both favorable and unfavorable views and experiences with XR-Bup. Understanding these preferences can inform protocols in jails that are considering implementation of XR-Bup treatment.

Informed Consent in Clinical Training: Perspectives from Medical Students and Faculty in Portugal.

The student-patient relationship represents the cornerstone of medical education, shaping future doctors' knowledge, skills and attitudes. While most patients allow student involvement in their care, some may express discomfort. Thus, obtaining explicit consent is essential to respect patients' right of autonomy. This study mainly aims to assess the practical application of informed consent by medical students and teachers regarding students' presence and participation in patients' care. An observational cross-sectional study was performed, and an online questionnaire was given to students and teachers at a single medical school, via institutional email. The study included 289 participants, namely 232 students and 57 teachers. While 81% of teachers reported always asking the patient's consent for students' presence, only 28% of students claimed this to be the case. Despite challenges like overcrowding and limited time, involving students in healthcare benefits both students and patients. Moreover, medical ethics education is crucial to foster compassionate care and promote ethical reasoning. The disparities found between teachers' practices and students' perspectives highlight the need to intervene and provide them with an adequate education on ethical values in clinical practice. Strategic interventions at institutional levels are required for a simultaneous high quality of patient care and clinical training.